Recruiting NCT05765929

Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

No phase Interventional Ankle Fracture, Bimalleolar Ankle Fracture, Trimalleolar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Non-operative treatment.
Who it may be relevant to: Registry conditions: Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Norway
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.

Other Non-operative treatment
Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated

Olerud Molander Score (OMAS) to measure a change over time [Time frame: 6 week, 12 weeks, 1year, 2 years]

Secondary outcome measures (6)

Manchester-Oxford Foot Questionnaire (MOxFQ) [Time frame: 6 week, 12 weeks, 1year, 2 years]
Range of Motion measured by a goniometer (ad modum Lindsjo) [Time frame: 6 week, 12 weeks, 1year, 2 years]
Numeric Rating Scale (NRS) [Time frame: 6 week, 12 weeks, 1year, 2 years]
Euroqol questionnaire (EQ- 5D) [Time frame: 6 week, 12 weeks, 1year, 2 years]
Registrations of complications/adverse events [Time frame: 0-2 years]
Posttraumatic osteoarthritis (OA) [Time frame: 2 years and 5 years]

-With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
With fractures in the distal 1/3 of fibula (not-Maisonneuve)
Enabling stability evaluation within 14 days after injury
18-75 years of age
with pre-injury walking ability without aids

\- With primary unstable ankle fractures, > 7mm medial clear space on primary radiographs
With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
With type A medial malleolus avulsion fractures < 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
With previous history ipsilateral ankle fracture
With previous history ipsilateral major ankle-/foot surgery
Who live outside the hospital catchment areas not available to follow up
With insufficient Norwegian or English language skills
Non-compliant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Norway · 1 center

NCT: NCT05765929 · 47891